Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-05-23
2026-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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No-T2D +MS / No-HF (control group)
25 patients without T2D +MS and without Heart Failure will be included in group 1.
Blood test
During the routine blood test of the patient, 4 more tubes of 4 milliliters (mL) will be collected to make a biological collection of PBMC and plasma for further analysis.
quality of life Questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about quality of life.
This is a descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. Each patient's health state is referred to in terms of a 5-digit code;
Levels of perceived problems are coded as follows:
* Level 1 is coded as a '1' (indicating no problem)
* Level 2 is coded as a '2' (indicating some problems)
* Level 3 is coded as a '3' (indicating extreme problems) For example, state 11223 indicates no problems with mobility and self-care, no problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems.
Diet habits questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about his diet habits.
This is an exploratory questionnaire that describes and quantifies the foods (pro- or anti-inflammatory) ingested by patients.
No-T2D +MS / HFpEF or HFmrEF
15 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
Blood test
During the routine blood test of the patient, 4 more tubes of 4 milliliters (mL) will be collected to make a biological collection of PBMC and plasma for further analysis.
quality of life Questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about quality of life.
This is a descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. Each patient's health state is referred to in terms of a 5-digit code;
Levels of perceived problems are coded as follows:
* Level 1 is coded as a '1' (indicating no problem)
* Level 2 is coded as a '2' (indicating some problems)
* Level 3 is coded as a '3' (indicating extreme problems) For example, state 11223 indicates no problems with mobility and self-care, no problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems.
Diet habits questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about his diet habits.
This is an exploratory questionnaire that describes and quantifies the foods (pro- or anti-inflammatory) ingested by patients.
T2D+MS / no-HF
30 patients presenting T2D +MS and without any type of HF will be included in group 3.
Blood test
During the routine blood test of the patient, 4 more tubes of 4 milliliters (mL) will be collected to make a biological collection of PBMC and plasma for further analysis.
quality of life Questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about quality of life.
This is a descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. Each patient's health state is referred to in terms of a 5-digit code;
Levels of perceived problems are coded as follows:
* Level 1 is coded as a '1' (indicating no problem)
* Level 2 is coded as a '2' (indicating some problems)
* Level 3 is coded as a '3' (indicating extreme problems) For example, state 11223 indicates no problems with mobility and self-care, no problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems.
Diet habits questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about his diet habits.
This is an exploratory questionnaire that describes and quantifies the foods (pro- or anti-inflammatory) ingested by patients.
T2D +MS / HFpEF or HFmrEF
30 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
Blood test
During the routine blood test of the patient, 4 more tubes of 4 milliliters (mL) will be collected to make a biological collection of PBMC and plasma for further analysis.
quality of life Questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about quality of life.
This is a descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. Each patient's health state is referred to in terms of a 5-digit code;
Levels of perceived problems are coded as follows:
* Level 1 is coded as a '1' (indicating no problem)
* Level 2 is coded as a '2' (indicating some problems)
* Level 3 is coded as a '3' (indicating extreme problems) For example, state 11223 indicates no problems with mobility and self-care, no problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems.
Diet habits questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about his diet habits.
This is an exploratory questionnaire that describes and quantifies the foods (pro- or anti-inflammatory) ingested by patients.
Interventions
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Blood test
During the routine blood test of the patient, 4 more tubes of 4 milliliters (mL) will be collected to make a biological collection of PBMC and plasma for further analysis.
quality of life Questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about quality of life.
This is a descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. Each patient's health state is referred to in terms of a 5-digit code;
Levels of perceived problems are coded as follows:
* Level 1 is coded as a '1' (indicating no problem)
* Level 2 is coded as a '2' (indicating some problems)
* Level 3 is coded as a '3' (indicating extreme problems) For example, state 11223 indicates no problems with mobility and self-care, no problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems.
Diet habits questionnaire
During the routine medical visit, the patient will be asked to fill in a short questionnaire about his diet habits.
This is an exploratory questionnaire that describes and quantifies the foods (pro- or anti-inflammatory) ingested by patients.
Eligibility Criteria
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Inclusion Criteria
* Patient coming on an empty stomach for the blood test
* Male or female aged between 40 and 80 inclusive
* Patient without systemic disease and/or without anti-inflammatory treatment
* Patient not objecting to this research
* Patient accepting the conservation of biological samples and the performance of genetic analyzes
Group 1: No-T2D +MS / No-HF (control group)
* Patient without T2D or MS and without heart failure coming to a consultation or day hospital for another reason (e.g. screening for atypical symptom, etc.)
Group 2: No-T2D +MS / HFpEF or HFmrEF
* Patient without T2D or MS
* HFpEF or HFmrEF. diagnosed
Group 3: T2D+MS / no-HF
* Patient diagnosed with T2D+MS
Group 4: T2D +MS / HFpEF or HFmrEF
* Patient diagnosed with T2D and MS
* HFpEF or HFmrEF. diagnosed
* History (ATCD) of cardiovascular disease (valvular (more than moderate valve disease), radiation, post-cardiotoxic chemotherapy, amyloidosis, etc.) other than HFpEF or HFmrEF
* Atrial fibrillation or permanent flutter ( paroxysmal AF is not a non-inclusion criterion: the rhythm must be sinus at the time of the ultrasound)
* Systemic disease and/or anti-inflammatory treatment
* ATCD of known coronary artery disease
* Unbalanced hypertension (\>160/100 mmHg)
* Pregnant and lactating women on questioning
* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Patients subject to a legal protection measure (guardianship, curators)
* Subject participating in another interventional research including a period of exclusion still in progress.
* Chronic kidney disease(GFR\<30ml/min/1.73m2)
Group 1: No-T2D +MS / No-HF (control group)
* Presence of diabetes (whatever the type) and MS
* Presence of heart failure or other known heart disease
Group 2: No-T2D +MS / HFpEF or HFmrEF
* Presence of diabetes (whatever the type) and MS
* No Heart failure
* Left Ventricular Ejection Fraction (LVEF) on ultrasound ≤ 40%
Group 3: T2D+MS / no-HF
* Without diabetes or other type of diabetes than T2D
* Presence of Heart failure or other known coronary artery disease
Group 4: T2D +MS / HFpEF or HFmrEF
* Absence of diabetes or presence of another type of diabetes than T2D
* Absence of Heart failure
* LVEF on ultrasound ≤ 40%
40 Years
80 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hopital Louis Pradel
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A02435-38
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL22_0580
Identifier Type: -
Identifier Source: org_study_id
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